Incidence of major bleeding complication of warfarin therapy in Japanese patients with atrial fibrillation
Incidence of major bleeding complication of warfarin therapy in Japanese patients with atrial fibrillation
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DOI：
10.1253/circj.71.761
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发表时间：
2007-05-01
影响因子：
3.3
通讯作者：
Fu, Long-Tai
中科院分区：
文献类型：
--
作者：
Suzuki, Shinya;Yamashita, Takeshi;Fu, Long-Tai
背景 在非瓣膜性心房颤动（NVAF）患者抗凝预防卒中过程中，出血是最严重的并发症。在西方国家，小剂量华法林导致大出血和颅内出血的发生率每年分别为0.4-1.3%和0.2%。本研究的目的是调查日本NVAF患者与华法林治疗相关的大出血的发生率和危险因素。方法与结果2004年8月至2005年7月，对667例接受华法林治疗的NVAF患者进行随访。目标凝血酶原时间-国际标准化比值 (PT-INR) 值设定为 1.6-2.6（低剂量华法林）。华法林暴露量为 503 患者年（平均 PT-INR 2.00 +/- 0.40）。随访期间，发生 12 例主要出血并发症（每患者年 2.38%），其中包括 3 例颅内出血（每患者年 0.60%）。在患者特征中，研究期间平均PT-INR≥2.27被确定为大出血的独立危险因素。结论日本NVAF患者接受小剂量华法林治疗时大出血和颅内出血的发生率分别为每患者年2.38%和0.60%，高于西方人。
Background During anticoagulation for prevention of stroke in patients with non-valvular atrial fibrillation (NVAF), bleeding is the most serious complication. In Western countries, the incidences of major bleeding and intracranial hemorrhages with low-dose warfarin are known to occur at a rate of 0.4-1.3% and 0.2% per year, respectively. The purpose of this study was to investigate the incidence and risk factors for major bleeding related with warfarin therapy in Japanese patients with NVAF.Methods and Results From August 2004 to July 2005, 667 NVAF patients treated with warfarin for NVAF were followed-up. The target prothrombin time-international normalized ratio (PT-INR) value was set at 1.6-2.6 (low-dose warfarin). The exposure on warfarin was 503 patient-years (average PT-INR 2.00 +/- 0.40). During the follow-up period, 12 major bleeding complications occurred (2.38% per patient-year), which included 3 intracranial hemorrhages (0.60% per patient-year). Among the patients' characteristics, average PT-INR >= 2.27 during the study was identified as an independent risk factor for major bleeding.Conclusions The incidence of major bleeding and intracranial hemorrhages in Japanese NVAF patients with low-dose warfarin therapy was 2.38% and 0.60% per patient-year, respectively, which is higher than in Westerners.